The present invention relates to pharmaceutical compositions containing selenite-containing compounds.
Inflammatory and/or degenerative alterations of the female cervix are a steadily increasing public health problem. Testing of cervical cell smears was developed by the Greek physician George Papanicolaou and the smears are classified according to the so-called Munich nomenclature II. Herein, the classification PAP I corresponds to a normal result, PAP II to a minor inflammatory and/or degenerative alteration, PAP III to cell profiles that cannot be assessed and need to be monitored, PAP IIID to a dysplasia, PAP IV to serious preliminary stages of carcinoma, and PAP V to a malign tumor. The forms of dysplasia PAP IIID and PAP IV are cytologically further differentiated into so-called “cervical intraepithelial neoplasias” (CIN) with the stages of CIN 1 for minor, CIN 2 for moderate, and CIN 3 for severe dysplasia. Analogously to the histological classification from CIN 1 (PAP IIID) to CIN 2 (also PAP IIID) to CIN 3 (PAP IV), it is also referred to the so-called Bethesda classification in the Anglo-American part of the world. Herein, the “Low-Grade Squamous Intraepithelial Lesion” (LSIL) corresponds to the Munich classification CIN 1, whereas cell alterations of a higher grade, i.e., “High-Grade Squamous Intraepithelial Lesions” (HSIL), correspond to the WHO classifications CIN 2 and CIN 3.
The average tendency for the regression of minor dysplasias (PAP IIID/CIN 1/LSIL) to a normal result (PAP I and PAP II, respectively) within a one-year period is as low as almost 15%. The tendency for the progression of minor dysplasias (PAP IIID/CIN 1/LSIL) to higher-grade dysplasias currently exhibits a mean annual transition probability of more than 7%, while the progression tendency of higher-grade dysplasias to carcinomas of the uterus is 0.74%.
Depending on the location and the severity of the cell alterations, the current international gynecological guidelines for the therapy of Cervical Intraepithelial Neoplasias (CIN) and microcarcinomas of the Cervix uteri comprise a destruction of the surface of the affected tissue, a conization with the aid of a scalpel, laser or LEEP (Loop Electrosurgical Excision Procedure) or a hysterectomy. Other non-surgical therapies are not known to date.
On the electrochemical level, inflammatory tissue processes are always associated with a (local) increase in so-called Reactive Oxygen Species (ROS), i.e., free radicals and peroxides. In the context of a spontaneous amelioration of these oxidative inflammatory factors, the competence of the body's own immune system and the levels of endogenous and exogenous antioxidants in the body play an important biological role. The anti-inflammatory and antiviral effects of antioxidative compositions have already been verified in numerous scientific publications and international patent documents (i.a. WO 2001/093910 A2 and WO 2003/047604 A1).